Package leaflet: Information for the patient

Akyris, 20 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Akyris is and what it is used for
What you need to know before taking Akyris
How to take Akyris
Possible side effects
How to store Akyris
Contents of the pack and other information

1. What Akyris is and what it is used for

Akyris is used to treat adult men with erectile dysfunction. This is a condition in which
a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil has been shown to significantly improve the ability to obtain an erection suitable for
sexual intercourse.
Akyris contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation, Akyris helps widen the
blood vessels of the penis, allowing blood to flow into the penis. This results in improved
erection. Akyris does not benefit patients who do not have erectile dysfunction.
It is important to be aware that Akyris does not work in the absence of sexual stimulation. The patient
and his partner should engage in foreplay, just as they would if the patient were not taking
a medicine for erectile dysfunction.

2. Important information before using Akyris

When not to use Akyris

if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina (chest pain). It has been shown that tadalafil enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
if the patient has severe heart disease or has had a heart attack within the last 90 days.
if the patient has had a stroke within the last 6 months.
if the patient has low blood pressure or uncontrolled high blood pressure.
if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye stroke".
if the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors, such as tadalafil, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Akyris, discuss this with your doctor.
Please remember that sexual activity involves a possible risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking this medicine, the patient should inform their doctor if any of the following apply:

sickle cell anemia (abnormal shape of red blood cells).
multiple myeloma (a bone marrow cancer).
leukemia (a blood cell cancer).
any deformity of the penis.
severe liver disease.
severe kidney disease.

It is not known whether Akyris is effective in patients:

after pelvic surgery.
after total or partial removal of the prostate gland with cutting of the nerves supplying the prostate (nerve-sparing radical prostatectomy).

If sudden worsening of vision or sudden vision loss occurs, or if vision becomes distorted or dimmed while taking Akyris, the patient should stop taking Akyris immediately and contact their doctor without delay.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden hearing deterioration occurs, the patient should stop taking Akyris and contact their doctor immediately.
Akyris is not intended for use in women.
Children and adolescents
Akyris is not intended for use in children and adolescents under 18 years of age.
Akyris with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Akyris if the patient is using nitrates.
Akyris may affect the action of certain medicines or other medicines may affect the action of Akyris. Tell your doctor or pharmacist if the patient is taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms caused by benign prostatic hyperplasia).
other medicines used to treat high blood pressure.
riociguat.
5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Taking Akyris with food, drink, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Akyris, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When Akyris was administered to dogs, a reduction in sperm production in the testes was observed.
A reduction in sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In some men taking Akyris during clinical trials, dizziness was reported. Therefore, patients should assess their individual response to the tablets before deciding to drive or operate machinery.
Akyris contains lactose and sodium
If the patient has an intolerance to certain sugars, they should consult their doctor before starting treatment with this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet; therefore, this medicine is considered "sodium-free".

3. How to take Akyris

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Akyris tablets are intended for oral use in men only. The tablets should be swallowed whole with a small amount of water. Akyris tablets may be taken with or without food.
The recommended dose is one 10 mg tablet taken prior to planned sexual activity.
If your doctor determines that the 10 mg dose is insufficient, then one 20 mg tablet should be taken as directed by your doctor.
Akyris tablets are intended for oral administration.
Akyris may be taken at least 30 minutes before planned sexual activity. Akyris may remain effective for up to 36 hours after taking the tablet.
Akyris should not be taken more than once in a 24-hour period. Akyris 10 mg and 20 mg are intended to be used as needed prior to planned sexual activity. Regular daily use is not recommended.
It is important to understand that Akyris will not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Akyris, he should avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Taking more than the recommended dose of Akyris
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below occur, stop taking the
medicine and seek immediate medical advice:

allergic reactions, including rash (uncommon).
chest pain – do not take nitrates, but seek immediate medical help (uncommon).
priapism, a prolonged and possibly painful erection after taking Akyris (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
sudden loss of vision (rare), distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (affects 1 to 10 out of 100 patients)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (affects 1 to 10 out of 1,000 patients)

dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (affects 1 to 10 out of 10,000 patients)

fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these patients
had pre-existing heart problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent
visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions
have been reported which were not observed during clinical trials. These include:

migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders manifesting as blood rush to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

Adverse reaction: dizziness was reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea was reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder or its representative
in Poland.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Akyris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Akyris contains

The active substance is tadalafil. Each coated tablet contains 20 mg of tadalafil.
Other ingredients are:
Tablet core: monohydrate lactose, pregelatinized starch (corn), colloidal anhydrous silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
Coating: hypromellose 2910, monohydrate lactose, titanium dioxide (E171), triacetin, talc, yellow iron oxide (E172), red iron oxide (E172).

What Akyris looks like and contents of the pack
Yellow, oval, film-coated tablets, with the engraved mark '20' on one side and smooth on the other side, approximately 12 mm x 7 mm in size.
Packaged in blisters made of PVC/Aclar (PCTFE)/Aluminium, contained in a cardboard box.
Pack sizes: 2, 4 and 8 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Special Product’s Line S.p.A.
Vita Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 (22) 375 92 00